This invention relates to the administration of sterile medical solutions and, more particularly, to a system and method for assuring that connections for fluid conduits for such solutions are maintained in an aseptic condition.
Sterile medical solutions, such as for intravenous feeding, transfusions, peritoneal dialysis and the like, are frequently administered to patients through a fluid conduit a portion of which may be surgically implanted in the body. In such cases, generally, an in-dwelling conduit, such as a sterile cannula, has one end located within the body while a second end remains outside the body for connection to fluid administration conduit tubing. The medical solutions or fluids are commercially available packaged in containers such as flexible plastic bags or glass bottles. Separate sterile, plastic, disposable administration tubing is used to pass the contents from such bags through the in-dwelling conduit into the patient's body. The bag, administration tubing and in-dwelling conduit must form a sterile fluid circuit. Therefore, it is essential that any connection between them be established and maintained in an aseptic condition to avoid contamination.
In continuous ambulatory peritoneal dialysis multiple daily exchanges of the sterile fluid are performed by the patient through a flexible in-dwelling cannula which is surgically implanted into the peritoneal cavity and sutured in place so that one end of the cannula is located within the cavity and the second end, or junction site end, remains outside the body cavity to form a convenient, reuseable, sterile fluid conduit to the patient's peritoneal cavity. The administration tubing set is connected to the dialysis fluid containing-flexible bag by a plastic attachment at one end, presently known as a "spike," and to the in-dwelling flexible cannula with a special, comparatively permanent, sterile attachment at the second end, known as the "junction site." The procedure of penetrating the bag with the spike is known as "spiking in." For each fluid administration, the patient "spikes in" to the fluid inlet port of a new bag and allows the fluid to flow by gravity into the peritoneal cavity. The bag is generally wrapped around the fluid inlet port-spike connection and remains in place on the body during ambulation, during which time the bag, administration tubing set and in-dwelling cannula remain attached to one another. After the prescribed fluid dwell time, the bag is placed below the patient's peritoneal cavity and fluid from the cavity is allowed to drain by gravity into the bag which is then replaced with a new bag and the process of fluid administration repeated.
Continuous ambulatory peritoneal dialysis requires that administration, dwell and emptying be performed at regular and frequent intervals, such as four times a day, by the patient. In order to prevent infection and to minimize touch contamination of the spike connection site during and between bag changes, prior art systems rely on wrapping the connection site with an antiseptic containing absorbent material, such as a povidone iodine impregnated gauze sponge, surrounding the gauze by subsequent layers of unsaturated gauze and taping the wrapping in place. For each administration, the wrapping is removed and replaced.
Present commercial attempts at minimizing environmental and touch contamination require the patient remove povidone iodine antiseptic sponges from a container, separately remove sterile gauze sponges from another container or envelope, apply the swab dressing to the spike connection site and place the gauze sponge around the dressing after which the patient must peel the backing off tape and separately apply it around the dressing and gauze sponges to hold them in place around the connection. Thus, not only must the patient make the tubing connection, that is "spiking in," but he must then immediately manually carry out the several described steps to establish and maintain an antiseptic connection at the "spiking in" site while it remains exposed to the atmosphere. Although the components for doing this are provided as a kit, they nevertheless require considerable handling resulting in technical difficulties which arise from attempting to hold the connection site away from any possible sources of contamination while simultaneously attempting to unpack the dressing and gauze and tape strips. Thus, the chance of mishandling increased. Moreover, the risk of touch contamination are considerably increased. In addition, the gauze sponges remain exposed to the air which can cause the antiseptic to dry out leaving it ineffective. Accordingly, not only are such prior art approaches inconvenient, but they also leave much to be desired from the standpoint of patient safety.